Persistent Pain After Breast Cancer Treatment (PPBCT) - Risk Factors and Pathophysiological Mechanisms

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01523132

Enrollment

545

Registered

2012-02-01

Start date

2011-11-30

Completion date

2014-11-30

Last updated

2016-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Lymphedema, Neuropathic Pain, Neuropathy, Persistent Pain

Brief summary

The study is a prospective cohort study following breast cancer patients from before surgery to one year after. The aims of the study are to determine risk factors that predispose to the development of persistent pain.

Detailed description

The aim of the study is 1) to determine pre-, intra and post surgical risk factors for persistent pain after breast cancer treatment 2) to examine the prevalence of persistent pain 6 and 12 months after surgery 3) provide a quantitative sensory testing (QST) profile of the patient population, measured pre surgery, 1 week and 12 months after surgery.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Diagnosed with breast cancer * 18 years or older

Exclusion criteria

* unable to give written consent * unable to understand Danish * Previous cosmetic surgery in the breast * Previous surgery in ipsilateral breast * Bilateral cancer * Concomitant corrective surgery on contralateral side * Pregnant * Other disease or injury in the nervous system * Psychiatric disease * Alcohol or drug abuse

Design outcomes

Primary

Measure	Time frame	Description
Risk factors predisposing for persistent pain after breast cancer treatment	12 months postoperative	Pre-, intra- and postoperative risk factors predisposing for persistent pain

Secondary

Measure	Time frame	Description
Acute pain after surgery for breast cancer	1 week postoperative	Prevalence of acute pain 1 week after surgery for breast cancer.
Test-Retest of QST after breast cancer treatment	12 months postoperative	A test-retest series of a subgroup of patients assessed with QST, to evaluate methodological reliability. Patients are scheduled to 2 QST assessments with a week between.
Prevalence of persistent pain after breast cancer treatment	12 months postoperative	—
QST profile 1 week after surgery for breast cancer	1 week postoperative	Detailed QST profile 1 week after surgery for breast cancer. Patients will be assessed with sensory mapping, followed by assessment of mechanical and thermal thresholds.
Correlation of persistent pain after breast cancer treatment and damage of the intercostobrachial nerve	12 months	—
Quantitative sensory testing: profile and correlation to persistent pain, sensory disturbances, signs of neuropathic pain, and treatment related factors	12 months	—
Genetic markers and the development of persistent pain after breast cancer treatment	12 months postoperative	—
Prevalence of sensory disturbances after breast cancer treatment	12 months	—

Countries

Denmark

Outcome results